CN104604252A - Adhesive anchors for bone conduction hearing devices - Google Patents

Adhesive anchors for bone conduction hearing devices Download PDF

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Publication number
CN104604252A
CN104604252A CN201380046547.9A CN201380046547A CN104604252A CN 104604252 A CN104604252 A CN 104604252A CN 201380046547 A CN201380046547 A CN 201380046547A CN 104604252 A CN104604252 A CN 104604252A
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CN
China
Prior art keywords
adhesive
user
external component
supporting pad
anchor log
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201380046547.9A
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Chinese (zh)
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CN104604252B (en
Inventor
J.F.卡西克二世
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Sophono Inc
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Sophono Inc
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Filing date
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Publication of CN104604252A publication Critical patent/CN104604252A/en
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Publication of CN104604252B publication Critical patent/CN104604252B/en
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Classifications

    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
    • H04R25/60Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R2460/00Details of hearing devices, i.e. of ear- or headphones covered by H04R1/10 or H04R5/033 but not provided for in any of their subgroups, or of hearing aids covered by H04R25/00 but not provided for in any of its subgroups
    • H04R2460/13Hearing devices using bone conduction transducers
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R5/00Stereophonic arrangements
    • H04R5/033Headphones for stereophonic communication
    • H04R5/0335Earpiece support, e.g. headbands or neckrests

Abstract

Provided are bone conducting hearing devices having a normal force that secures the device to a user. A removable adhesive anchor secures an external component of the bone conducting hearing device to the user and provides reliable connecting that is comfortable, such as by a substantially uniform force generation over the contact area between the device and the user. Because the adhesive anchor is removable, a user can readily and reliably remove the device or connect the device, as desired. Also provide are methods of connecting any of the bone conducting hearing devices provided herein to a user, including the mastoid process of the user.

Description

For the adhesive anchor log of bone conduction hearing device
The cross reference of related application
This application claims the application number submitted on March 14th, 2013 is 13/804, the application number that the U.S. Patent application of 420 and on September 6th, 2012 submit to is 61/697, the rights and interests of the U.S. Provisional Patent Application of 427, wherein each at this by reference to be incorporated herein in the scope not inconsistent with present disclosure.
Technical field
There is provided herein bone conduction hearing device, it has the mechanism of the special configuration of the sidepiece for this device being fixed to head.
Background technology
Bone conduction hearing device has large with important market at hearing devices or field of hearing aids.There is the bone-conduction device of five kinds of main Types, comprising: (1) outside bone-conduction device, wherein vibrator remains to the sidepiece (such as, U.S. Patent number 7,822,215) of head by the band of lateral circular head; (2) bone anchor formula hearing devices, wherein screw is through placed in skull, and vibrator transducer hang on screw sidepiece (see, such as, Cochlear company hearing aids); (3) magnetic bone conduction hearing implant, wherein magnet is implanted and be attached to skull, and with the magnet of outside location provides normal force to the sidepiece of head vibrator to be remained to head (such as, PCT publication number WO201 0/105601); (4) tooth vibrator, wherein vibrator is attached to tooth or dental implant (such as, U.S. Patent number 7,682,303); (5) initiatively implantable bone conduction device, wherein transducer is implanted under skin to make skull vibrate (such as, vibrant Med-EI Hearing Technology; otologics).
For outside bone conduction hearing device, an importance guarantees that external component is fixed to the sidepiece of head and does not have the impact on disadvantageous biology.Such as, The Australianand New Zealand J.of Aud.30 (2): 113-113 (2008) c of the people such as Raicevich describes " Long-Time Service of the bone vibrator that headband is worn is always with skin ulcer; and; in severe cases, with the physiological atrophy at contact point place." various research reports dermoreaction around adjacency section; and according to Holgers hierarchy system (people such as Holgers; U.S. publication Otology 9 (1): 56-59 (1 988)), they to be marked; the level range of this system extrude from skin irritatin and erythema to implant cause apparent infection (McDermott etc., 2009; Van de Bert etc., 2010; De Wolf etc., 2008; Wazen etc., 2008; Priwan and Granstrom, 2005; Badran etc., 2009; De Wolf etc., 2009; Faber etc., 2009), and rank score value can be comprised, such as: 0: reactionless; 1: slightly rubescent; 2: red and moist tissue; 3: granulation tissue; With 4: need the infection of removing adjacency section.
Example for various systems device being fixed to user comprises United States Patent (USP) 7,822,215 (headbands); 7,809,147 (glasses); U.S. Patent Publication 2009/0290730 (annular retaining device); U.S. Patent Publication 2007/0071258 (two-sided tape).But, disclosed in this area, various device has very large restriction because they otherwise do not have fully and enough power is reliably provided, or provide too many power, be disgusting or uncomfortable, or need the implant with adjoint cost and operation intervention.
There is provided reliable herein and cosily apply the device of contact force to hearing devices of normal direction orientation, it is by the skull of this hearing devices compression user.The device avoids produce to insecure power, uneven power distributes or very tedious parts are relevant problem, thus be conducive to this device wear performance and durability, comprise the use of ultra-long time.
Summary of the invention
Disclosed herein is the external component of bone conduction hearing device to the device on the surface of user and correlation technique.
In one aspect, provide a kind of bone conduction hearing device or hearing aids herein, comprise external component and this external component is fixed to the removable adhesive agent anchor log on surface of user.In this, this removable adhesive agent anchor log produces normal force so that this external component is fixed to user.In one embodiment, this removable adhesive agent anchor log is configured to the normal force desired by generation.On the other hand, the present invention is the removable adhesive agent anchor log being connected to user's (such as covering the skin of the head area of skull) for bone being vibrated hearing aids.
In one aspect, this removable adhesive agent anchor log is selected and is designed to produce enough contact forces to provide good physical contact between the oscillating component and the skull of user of hearing aids.In one aspect, the combination of adhesive strength of the curvature of the bone under this flexing mechanism by adhesive anchor log and user's contact surface and the adhesive phase that hearing aid device bonded to user surface realizes.In yet another aspect, rigidity and the geometry on smooth hearing aids external component surface combine with the curvature of user's bone below.In these two, produce dynamic balance in the tissue of interaction between various parts below adhesive anchor log, adhesive anchor log has by along the perimeter limited away from the normal force in the direction of user and correspondent method to force direction towards the middle section of user.The middle section with the normal force direction from hearing aids towards user ensure that the good physical contact between skull and hearing aids, and the corresponding good vibration passing from hearing aids to skull.On the one hand, this skull is corresponding to mastoidea or the head area with adjoint curvature.
By this way, by corresponding to the interaction of adhesive anchor log of the surface configuration (surface configuration of the head area below such as adhesive anchor log) of user, smooth and surface that is anti-flexing is forced to the geometry becoming flexing or deflection.In other words, in use, usually smooth surface is forced bending geometry, supervenes along the smooth power of the trend acting on edge away from user and towards the normal orientation of hearing aid device.Statics needs this power to be balanced, because in use, preferably there is not the movement relative to bone below of device or device feature.Equilibrant force appears at the middle section below the outer surface being placed in hearing aids, to provide physical contact closely between outside hearing aids and user.
This configuration is more favourable, because the characteristic of various parts is avoided the pressure spot on user by selection, keeps enough contact forces simultaneously.Adhesive anchor log is for bending firmer or more counter-bending, then larger in the contact force of middle section generation, as long as provide the adhesive portion of bringing into conformal contact enough strong between adhesive anchor log and user.
In one embodiment, the present invention is the system of the hearing aids for installing from outside to the skull transmission vibration of user.In one aspect, this system comprises external component surface and reversibly external component surface is fixed to the adhesive sticker anchor on user surface.For bone conduction hearing aid system, the surface of user preferably covers head area (also referred to as mastoidea).In use, this external component surface produces normal force distribution with the adhesive sticker anchor log being connected to this head area.The distribution of this normal force refer to have along towards the power in the direction of user contact area and have along away from another region of the power in the direction of user.Usually, this system in use has force direction away from the perimeter of head area and the direction of the power middle section towards head area.This system is configured to the middle section obtaining the contact force providing enough between outside parts surface and head area, reliably to transmit vibration from outside hearing aids to head area.
In one embodiment, this adhesive sticker anchor log be included in user surface and external component surperficial between adhesive phase, and this adhesive phase is shaped as with a part of bringing into conformal contact of this head area and covers a part for this head area.Especially, although this head area is between individual (male sex, women, children), dimensionally may be different, always there is the circular conic protruding portions that there is the adhesive phase side of being placed thereon.So this mastoid process is bent downwardly from this circular conic protruding portions according to the distance of distance central conical protuberance.This geometry is utilized by apparatus and method provided herein thus produces good contact force in reliable and cost-effective mode, keeps high user's comfortableness simultaneously.
In one aspect, external component surface is the contact pad of the flat surfaces had for being connected to adhesive sticker anchor log, is connected to the surface vibration of relative positioning the vibrator of hearing aid device.Such as, cylindrical metal pad can be connected to hearing aid device at cylindrical face place, and the opposite face of cylinder is corresponding to the external component surface being in flat-surface shapes.The accurate shape of this flat surfaces is not crucial, as long as there is enough large surface area to guarantee the covering in the prominent region with enough curvature or displacement breast.In one aspect, this flat-surface shapes is circular or circle, thus provides easier aligning relative to the shape of multiaspect." circular " refers to that the size of contact-making surface does not depart from and exceedes average diameter 10%, and average diameter D is calculated as follows:
D = 4 π A
Wherein, A is the surface area on this surface.On the one hand, this flat-surface shapes is circular, has to be selected to be more than or equal to 5 millimeters and the diameter being less than or equal to the scope of 25 millimeters, and is more preferably selected from and is more than or equal to 10 millimeters and the scope being less than or equal to 20 millimeters.
On the one hand, this surface configuration has to be selected from and is more than or equal to 1 centimetre and the average diameter being less than or equal to the scope of 2 centimetres, or alternatively, is more than or equal to 0.7 square centimeter and is less than or equal to the surface area of 3.5 square centimeters.This surface area can be selected based on the size of the size of user (such as, the shape of mastoid process and curvature), ossiphone, weight and shape and the hearing loss characteristic disposed by hearing aids.
In one embodiment, this adhesive sticker anchor log comprises the adhesive phase had corresponding to the surface configuration of this contact pad flat surfaces and the surface configuration of surface area and surface area, such as, be round-shaped.In this respect, " corresponding to " refers to that the absolute deviation of any parameter is no more than 10%, is no more than 5%, is no more than 1% or within 1%, such as, and the diameter within selected percentage each other or surface area.
On the one hand, this adhesive sticker anchor log comprises the supporting pad with upper surface and lower surface, for the upper surface of supporting pad being connected to the upper adhesive phase on external component surface, with for the lower surface of supporting pad being connected to the lower adhesive phase of head area.
In one embodiment, after supporting pad is configured as and is placed on ear in the inconspicuous mode of vision.In this embodiment, the shape of supporting pad has the concave edge edge for locating near ear and the flange relative with concave edge edge for locating farthest apart from ear.By this way, in use, this supporting pad after ear around bending.
Upper adhesive phase has upper adhesive layer surface shape, keeps paying somebody's debt and expecting repayment later the boss feature structure with the boss feature shapes corresponding to upper adhesive layer surface shape comprised for receiving upper adhesive phase." boss feature structure " refers in the raised elements for placing and hold on the surface of this adhesive phase or relief feature structure.Correspondingly, this boss feature structure limit on the upper surface of supporting pad receiving body amass.Such as, for the upper adhesive phase of circle, this boss feature structure can be annular.For upper adhesive phase that is oval or rectangle, boss feature is also correspondingly oval or rectangle.The height of boss feature structure can be corresponding with the thickness of at least overlying adhesive, comprises any lining or do not comprise any lining.On the one hand, the height of boss feature structure is within about 10% of the thickness of the adhesive phase will held by boss feature structure.On the one hand, boss feature structure is enough high, can also receive and hold hearing aids external component surface.On the one hand, boss feature structure has the height of about 0.03 inch, or is selected from and is more than or equal to 0.5 millimeter and the height being less than or equal to the scope of 1.5 millimeters.On the one hand, boss height is selected as the accurate placement being convenient to both adhesive phase and external component surface.On the one hand, first upper adhesive phase is applied to external component surface, and this combination is placed in reception volume.Alternately, first upper adhesive phase is positioned in and receives in volume, then with external component intimate surface contact.In both cases, the accurate placement of boss feature structure accessory external parts surface, and thus auxiliary phase for the location of the head area of user.Appropriate location is very important, to guarantee that normal direction contact force is placed in external component lower face, thus guarantees the good contact between hearing aids vibrator and skull.
Any system provided in this article can have supporting pad and lower adhesive phase, and each have the surface configuration corresponded to each other.
System provided in this article can conduct further description in surface area.Such as, supporting pad has surface area, and external component surface has surface area, wherein, the ratio of the surface area on supporting pad and external component surface be selected from be more than or equal to 1 and be less than or equal to 5 scope or its any subrange.
In one embodiment, this adhesive sticker anchor log has and is selected from following one or more physical properties: be selected from and be less than or equal to 5 millimeters and be more than or equal to 0.1 millimeter, or the thickness in scope between about 10 mils and 1000 mils; Under being provided in the effect of the load of about 0.8 pound to 2.5 pounds that are applied to outer end, be selected from the clean bending rigidity of the outer end bending value of the scope of 0.08 inch to 0.25 inch.On the one hand, adhesive strength be selected as enough strong with keep deflection and can not from any corresponding surface depart from layering.On the one hand, this system is configured to provide be selected from and is more than or equal to 0.1 newton and the clean counter-bending power or the effective elastic constant that are less than or equal to the scope of about 5 newton.
On the one hand, the load applied is produced by the lower adhesive phase being connected to the curved surface correspondingly making supporting pad bend.Such as, the load applied can be selected from and be more than or equal to 1 pound (about 4.4 newton) and the scope being less than or equal to 2 pounds (8.8 newton).On the one hand, any adhesive anchor log fallen in this parameter area may be used for hearing aids to anchor to user.
In one embodiment, this adhesive phase is two-sided movable medical adhesive.The example of this type of adhesive comprises two painting layers of polyethylene medical adhesive tape, comprises optical clear adhesive tape, such as MED 3044 (AveryDennison Corporation-Vancive) or 3M.On the one hand, the thickness of adhesive anchor log layer is in use selected from and is more than or equal to 0.1 millimeter and is less than or equal to 1 millimeter, or the scope of about 0.2 millimeter to 0.4 millimeter.
In another embodiment, the present invention is a kind of for connecting the adhesive sticker hearing aids pad of hearing aids to user surface.On the one hand, this hearing aids pad comprises, combination have upper surface and lower surface can conformal supporting pad, for be connected to supporting pad upper surface for supporting pad is connected to hearing aids external component surface upper adhesive phase and be used for being connected to supporting pad lower surface for lower adhesive phase supporting pad being connected to user surface.Optionally, the boss feature structure on supporting pad upper surface receives and locates adhesive phase on the upper surface of supporting pad.In use, the deflection that supporting pad is divided relative to inside by outside point and consistent with the curvature on user surface, with produce along the outward flange of supporting pad towards upper power and in inner region towards under power, thus can be conformal supporting pad and user surface between good contact is provided.On the one hand, when being positioned at above head area by adhesive sticker hearing aids pad, middle section is pacified position above circular conic protruding portions and is not deflected at this supporting pad.But due to mastoid process surface curvature, the skin surface therefore covered and corresponding supporting pad in use deflect and bend.This deflection is reflected in the contact force that supporting pad middle section produces.
On the one hand, upper adhesive phase is connected to the external component surface of hearing aids.On the one hand, this adhesive sticker hearing aids spacer has the surface area of the scope being selected from 1 square centimeter to 15 square centimeters, and this surface area can obtain for contacting with the physical skin covering head area.
On the one hand, the middle section of any system described herein is defined as inner most 10%, 20% or 50% of this surface area.On the one hand, the exterior domain of any system described herein is defined as outermost 20%, 50% or 70% of this surface area.On the one hand, this middle section and the external component surface location corresponded to relative to user surface.On the one hand, interior and position that is exterior domain is determined by rule of thumb, such as comprise accordingly inside with outside normal force at least about 70% to 100% or any scope wherein.
Present invention also offers the various methods relevant to device described herein.On the one hand, provide the method for a kind of fixing bone conduction hearing device to the skin of the head area of covering user, comprise by any adhesive sticker anchor log described herein.In one embodiment, the method comprise adhesive anchor log is positioned at the head area covering user skin on and bone conduction hearing device is connected to this adhesive sticker anchor log to produce outside power in the skin being positioned at the outer beneath portions of adhesive anchor log.This outside power because the contact surface of bone conduction hearing device and/or adhesive anchor log shelve state trend in smooth, and its outer edges place, mastoid surface and skin contact surface are bent away from this hearing aid device.Therefore, the power of exterior domain is away from user.Therefore statics need outside power by being positioned at the inside dynamic balance in the skin of beneath portions in adhesive anchor log.Bone conduction hearing device is reliably fixed to user by this inside power.
In one embodiment, the method also comprises the step of being out of shape by adhesive anchor log (such as supporting pad), with consistent with the shape of the mastoid process below adhesive anchor log, produces outside power thus.On the one hand, the state of shelving of adhesive anchor log and supporting pad is smooth, with when adhesive anchor log and supporting pad consistent with the curved surface shape of user time, produce outside power.On the one hand, when only using adhesive tape, the firm flat geometry on hearing aids external component surface and curvature and binder combination produce outside power.
In one embodiment, any method and apparatus be easily installed to skin and the disposable adhesive sticker anchor log removed from skin is relevant.When not sacrificing reliable physical contact, this is particularly advantageous, because avoid needs bone anchor being determined to adjacency section.Therefore, hearing aid device is removed in direct and easy mode and is connected.This system can be designed as the use providing the scope exceeding about a day, such as, is removed by adhesive sticker anchor log before sleep from skin and hearing aids, and this hearing aids and new adhesive sticker anchor log prepare to be used for using for second day.Alternately, this adhesive sticker anchor log, such as supporting pad part, can be configured to reusable.As required, this adhesive phase can be replaced to guarantee that enough adhesive strengths are kept.On the one hand, this adhesive phase is departed from by with user surface and/or hearing aids external component skin lamination, and can not user surface and/or external component surperficial stay obvious or observable residual.
On the one hand, this normal force can change as required in the scope of power, such as, depend on the geometry of operating condition and/or device.Usually, more greatly or heavier device need larger normal force so that this device is fixed to user than corresponding less or lighter device.On the one hand, the normal force be applied in any device or where method in office is selected from and is more than or equal to 0.25 newton and the scope being less than or equal to 10 newton.On the one hand, this power by external component and below user surface between the contact surface that limits of contact area on be uniform substantially, thus avoid or minimize undesired pressure spot." substantially even " refers to that the power (such as, pressure) on the area limited is less than 20% with the power expected or the difference of pressure, is less than 10% or be less than 5%, such as, mean force on whole contact-making surface area or pressure.Alternately, the distribution of power can functionally to distribute thus to avoid making user's irriate to define fully, such as, time too high to the power on specific region relevant skin irritatin, and local organization ischemic in severe cases and linked groups's ulcer or necrosis.Such functional descriptions can be quantified as 0 (having no significant effect) according to Holgers categorizing system, and 1 slight rubescent and slight swelling, the redness of 2 moderate swellings and moist tissue, 3 granulations, cause the infection that implant removes.On the one hand, the score average out to 0 or 1 of device provided in this article under such system.
In one embodiment, this normal force be selected as bone conduction hearing device and below tissue between the contact being less than about 3.7 kPas is provided.
On the one hand, normal force is applied on contact surface area, and the contact surface area that disperses fully on the surface user of such as exerting all one's strength to avoid pressure spot, such as, is more than or equal to 1 square centimeter and is less than or equal to the surface area of 5 square centimeters.
There is provided herein the embodiment of some adhesive anchor logs.In one embodiment, this adhesive anchor log comprises the cantilever with first end and the second end, and is connected to the binder parts of user.The first end of this cantilever is connected to this binder parts, and the second end of this cantilever is connected to this external component.In this configuration, this cantilever produces normal force.This cantilever can be connected to external component towards outer surface, wherein normal force is applied to towards outer surface and thus towards covering the skin of skull, as along the direction (such as, normal force) perpendicular to skin and skull surface.Alternately, the second end of this cantilever can be connected to other surfaces of external component, comprise except towards except surface outside surface.Such as, the second end of this cantilever can be shaped to assemble around this external component, the power corresponding to the outer edge surface around this external component to make normal force and apply.On the one hand, the second end of this cantilever to be connected to around the outer edge surface of outer surface and this external component one or more the two, such as, with cup-like structure.In like fashion, between cantilever and external component, there is the contact area of increase, better this external component is fixed thus, and control in addition on from cantilever to external component and thus to the distribution of the power on user surface.
In another embodiment, this adhesive anchor log comprises the adhesive this external component being fixed to user.On the one hand, this adhesive is the adhesive tape with first end and the second end, and this first end is fixed to user in first position, and this second end is fixed to user in second position.This first and second position is separated by separation distance.This adhesive tape has the middle body being fixed to the outer surface of external component between this first and second end.In order to promote the power expected or pressure distribution on the skin surface above the skull of this device of location, this external component comprises the spring element being connected to transducer and external shell assembly further.This transducer portion can involving vibrations device and preferably against user surface location.This external shell assembly has the first surface being connected to this spring element and the second surface being connected to this adhesive tape.First and second surfaces of this external shell assembly toward each other and the middle body of this adhesive tape normal force is applied on the second surface of external shell assembly, so that this transducer is fixed to user, comprise via this spring element.On the one hand, this housing unit and this transducer form single single unit system, have internal capacity, and in this internal capacity, one or more spring element promotes from this outer housing part to this transducer and the transmission to the power this user surface.
On the one hand, the spacing distance between the first and second positions fixing the user of this adhesive element or adhesive tape is selected as reliably this device being fixed to this user, comprises to produce the normal force expected.On the one hand, this spacing distance is more than or equal to 1 centimetre and is less than or equal to 6 centimetres.
On the one hand, this adhesive tape is formed, as circular shape.In this respect, first and second ends of this adhesive tape form the part produced with the periphery of the adhesive of the periphery adhesive contact area of user, and this middle body is limited in the region that formed by the periphery of this adhesive, so that this external component is fixed to this adhesive tape.
In one embodiment, this binder parts is adhesive, such as contact adhesive, contact adhesive or temperature-independent adhesive.On the one hand, this adhesive is removable, because with often leave the permanent adhesives of a large amount of nubbins when removing compared with, it can remove from user surface as required and can not leave a large amount of remaining residues.Removable adhesive agent and user surface and/or this device form temporary bond and can remove as required, such as every day or the every day of being longer than.On the one hand, this removable adhesive agent can be used repeatedly.On the one hand, this removable adhesive agent can be removed and throw away, the removable adhesive agent that each use is new.On the one hand, this removable adhesive agent is adhesive tape, such as single or double adhesive tape.
In one embodiment, this spring element is configured between this transducer and skull, provide best substantially equally distributed normal force on the contact-making surface of the transducer contacted with user.This embodiment is for guaranteeing that the wearing comfort of this device is very important.Functionally, the substantially uneven power distribution on the contact surface between device and user be embodied in expressed by user uncomfortable and adjoint be described to not want or in rubefaction in less desirable " pressure spot " region.If do not disposed, such pressure spot may cause tissue frustrate scratch and can cause necrosis when serious.Avoiding undesirable pressure spot to be very important by the power reduced in this region, comprising by reducing normal force or partially-formed further by this device and user's surface contact.On the one hand, spring element is positioned as providing uniform power to distribute.On the one hand, this uniform power distribution is by providing multiple spring element to realize.
Therefore, on the one hand, any apparatus and method provided in this article relate to the rubescent pressure spot will caused to avoid producing pressure that is uncomfortable or user's skin with this hearing devices shaping surface of user's skin contact further, such as, by substantially distributing normal force on whole user's skin contact surface area equably.On the one hand, this transducer contact surface has the surface area in the scope that is selected between 1 square centimeter and 10 square centimeters, and this surface area contacts with the physical skin covering skull.
One of advantage of this technology can produce suitable normal force and not need may be uncomfortable, annoying or undue less desirable parts of interfering.Therefore, one embodiment of the present of invention be any without adjacent portion, without headband or both without the bone conduction hearing device of applying normal force or method.Be widely used in the parts this device being fixed to head of the most of circumference referring to cross over user's skull without headband, and glasses, headphone and soft ribbons can be comprised.
In one embodiment, any hearing devices provided in this article and method relevant with it relate to the external component part contacted with user, it is configured and is configured as the skin assembling against covering user's skull, comprises and is configured to guarantee to avoid undesired pressure spot.On the one hand, the inner surface of this external component and the skin bringing into conformal contact of covering user skull.In this embodiment, be formed with and help make this external component have the profile of the shape about skull towards interior surface, thus towards interior surface and below user surface between bringing into conformal contact is provided.
On the one hand, any one hearing devices provided in this article also comprises one or more internal magnets, and for generation of a part for normal force, wherein, this magnet to be positioned under user surface and to be connected with this external component magnetic.
In one embodiment, one or more external magnets is positioned at the outside on user surface and is connected to this external component, and wherein, this external magnets is connected with this internal magnets magnetic.
In another embodiment, a kind of method for bone conduction hearing device being fixed to the skin covering user head area being provided herein, comprising for any device disclosed herein.On the one hand, the method is by being connected to the skin in the region adjacent with mastoid process by one end of adhesive anchor log.Second end of adhesive anchor log is connected to this bone conduction hearing device.Power is applied on this bone conduction hearing device by this adhesive anchor log along normal orientation, wherein, is substantially uniform on the contact surface area of power between this bone conduction hearing device and user that user applies.This adhesive anchor log can be any adhesive anchor log provided in this article.On the one hand, this surface area contact is more than or equal to 1 square centimeter and is less than or equal to 10 square centimeters, or its norator scope, such as, between about 2 square centimeters and 7 square centimeters.On the one hand, substantially uniform power distribution on this contact surface area is passed through by the contact surface of this external component (such as at least in part, this inner surface) being shaped realizes, to provide bringing into conformal contact between the skull below the contact surface and this contact surface of this external component.
Do not wish the constraint by any particular theory, the view of the general principle relevant to apparatus and method disclosed herein or the discussion of understanding may be had herein.Should be realized that embodiments of the invention still may be exercisable and useful regardless of the explanation of any machinery or the final correctness of hypothesis.
Accompanying drawing explanation
Fig. 1 shows the headband structure for fixing hearing devices against skull.
Fig. 2 shows the soft ribbons structure for fixing hearing devices against skull.
Fig. 3 shows the magnetic texure for fixing hearing devices against skull.
Fig. 4 shows the adhesive for fixing hearing devices against skull.
Fig. 5 shows adhesive and spring for fixing hearing devices against skull.
Fig. 6 shows adhesive tape and spring structure for fixing hearing devices against skull.
Fig. 7 A shows adhesive sticker hearing aids pad.Fig. 7 B is vertical view (upper figure) and end view (figure below).Fig. 7 C is the schematic diagram illustrating of the different parts that this adhesive sticker hearing aids pad is shown.
Fig. 8 is a kind of hearing aid device, comprises the pad being attached to the applicable vibrator used together with this system shown in Fig. 7 A-7C.
Fig. 9 A is vertical view (left figure) and the end view (right figure) of the adhesive pad that applicable children use.Fig. 9 B is the adhesive pad used together with the hearing aids pad of Fig. 8.Due to the curvature of bone below and the flat surfaces of this pad, produce power distribution, wherein middle section has towards the normal force of user's orientation, and perimeter has the normal force towards device orientation.
Figure 10 A is the end view for the hearing aids pad used of being grown up in the bonding hearing aids pad of Fig. 7 and Fig. 8.Figure 10 B is when adhering to user, the adhesive pad used together with the hearing aids pad in Fig. 8, and the curvature showing bone makes this bonding hearing aids pad bend, and causes the similar power distribution as summed up in 9B.
Figure 11 shows the hearing aid device with the external component surface being operably connected to it.
Embodiment
As used herein, " external component " of bone conduction hearing device refers to the part being positioned at outside device relative to the skin of user.The canonical dissection of this external component is comprised detection sound and by vibrator units, the sound detected is converted to the transducer of vibration.Those vibrations are passed to skull, and the vibration of skull is at least detected by the downstream part of the auditory system of user, impels user to listen thus.In contrast, internal part refers to any part of the device being implanted to (such as, under the skin) in user.On the one hand, any apparatus and method provided in this article relate to the device without any internal part." external component surface " refers to the surface being configured to the hearing aids being connected to user surface (such as, by adhesive anchor log).This external component surface can be smooth and relative stiffness, such as, formed by the metal dish of the vibrator being physically connected to this hearing aids.This external component surface can be magnet or be manufactured by magnetisable material, for being connected with magnet or magnetisable material magnetic.
" adhesive anchor log " refers to the part of the device this external component being fixed to user surface (such as, covering the surface of the skin of skull).On the one hand, the part of this skull is a part for temporal bone, is included in the mastoid process part of the skull above ear and in region around." dismountable " adhesive anchor log refers to the structure of this external component and promotes repeatedly remove from user surface and fix the adhesive anchor log of this external component to user surface.Alternately, this system can be configured to disposable system, and wherein, low cost part is thrown away after using and replaced for follow-up use by new part.
Removable, in some aspects, refer to and can be removed from surface by user, and without any need for the parts of special instrument or process, such as, leave surface by these parts are peeled off or peeled off, and a large amount of materials can not be left.Any material retained is generally residual adhesive, and can wiping easily or wash off, and can not stimulate surface, such as skin surface.On the one hand, these removable parts are reusable.On the one hand, these dismountable parts are disposable, because once be removed, this removable part can be dropped and use new removable part.On the one hand, these removable parts are adhesive sticker anchor logs.On the one hand, these removable parts are the parts of the adhesive sticker anchor log comprising multiple build-up member.Such as, adhesive phase can be disposable, and the supporting pad that this adhesive phase connects is reusable.
" normal force " refers to the power of the direction applying along the surface be fixed thereon perpendicular to this external component.This normal force can relative to user outside or inside orientation.This normal force also can according to comprise this external component hearing devices physical contact user surface on power distributes, pressure distribution or average pressure be described.Average pressure is calculated as this normal force and is applied in contact surface area thereon divided by power.On the one hand, this power is applied to and makes this power or pressure substantially even on this contact-making surface area, thus avoids undesirable pressure spot.On the one hand, this normal force and contact surface area are selected as guaranteeing that gained pressure is enough low, the capillary in the capillary below this bone conduction hearing device is closed and is avoided.On the one hand, in long-time section, by hour in units of measure, this pressure is less than about 3.7kPa.
Refer to user surface " bringing into conformal contact " and cover user surface and the parts that determined by shape or the profile on this user surface of its contact surface shape.Functionally, bringing into conformal contact is by being uniformly distributed the power that is applied on contact surface area and guaranteeing to avoid unnecessary pressure spot.On the contrary, the device of bringing into conformal contact is not had to suffer following shortcoming: any inhomogeneities in user's surface configuration often stands higher local power and applies, and, therefore stand undesirable pressure spot.
" bending rigidity " is the mechanical performance of material, device or layer, describes the resistance to applied bending moment of material, device or layer.Usually, bending rigidity is defined as the modulus of material, device or layer and the product of inertia area square.The material with non-homogeneous bending rigidity is optionally described according to " volume " or " on average " bending rigidity for whole material layer.An importance of the present invention is the suitable selection that the bonding strength of bending rigidity and adhesive or adhesive linkage combines.If bending rigidity is too high and bonding strength is too low, then material will be not consistent with head area, but can leave bending user surface to post-buckling, smooth geometry to be flattened, thus be pulled away from from adhesive phase or be pulled away from from skin by adhesive phase.If bending rigidity is too low, then this layer middle body to correspond to the normal force of contact force will correspondingly too low, the physical contact between this hearing aids and skull for reliably and the vibration passing of high-fidelity also too low.Therefore, there is provided herein particular elements, it has selects to realize comfortable and physical property that is reliable contacts power, thus releasedly hearing aid device is connected to head area to carry out vibration passing, and therefore carries out hearing and assist.The example of a suitable bending rigidity is the bending moment of about 1.65 pounds applied, comprise the scope from about 1 pound to about 2 pounds, with such as outside end produce from the displacement of smooth generation about 0.165 inch or skew, comprise the displacement from the scope of about 0.08 inch to about 0.25 inch or skew.
The present invention understands further by following non-limiting example.The list of references quoted herein is incorporated to by way of reference herein under the prerequisite without prejudice to disclosure herein.Although description herein contains much particularity, these scopes that should not be construed as limiting the invention, but only provide some current explanations preferred embodiment of the present invention.Such as, thus scope of the present invention should be determined by claims and equivalent thereof, instead of is determined by the embodiment provided.
Example 1: headband
Fig. 1-2 shows wherein headband 100 (Fig. 1) or soft ribbons 200 (Fig. 2) and provides the embodiment of the normal force 15 external component 20 of hearing devices 10 being fixed to user surface 17.The present embodiment suffers many shortcomings, and such as, in use, particularly about providing the good normal force limiting and control, this band 100 or 200 is uncomfortable, plain and unreliable.Therefore, one aspect of the present invention relates to is not headband, soft ribbons or any other adhesive anchor log around the band of head.
Example 2: magnet
Fig. 3 shows wherein magnet provides normal force external component 20 to be fixed to the embodiment on user surface 17.In the present embodiment, this magnet comprises inner magnet 300 and is fixed on the external magnet 310 in magnet distance piece 311 relative to the user surface 17 corresponding to the skin 18 covering skull 19.In this respect, magnet 300 and 310 can be considered to the removable adhesive anchor log of forming section, because when removing its external component, this inner magnet 300 keeps being implanted in user.On the one hand, this magnet distance piece 311 has the inner surface 312 be shaped as with skin 18 bringing into conformal contact covering skull 19.
Example 3: adhesive
Fig. 4 describes the simplest form of the adhesive anchor log 400 external component 20 being fixed to user surface 17.In one embodiment, this adhesive anchor log is the adhesive material of the viscosity with the first and second surfaces, and make first end cling user surface 17, second surface clings external component 20.The shortcoming of this embodiment is that produced normal force 15 is usually too low to such an extent as to cannot provide good vibration passing.This is represented by the short length of normal force arrow 15.
Fig. 7-10 shows an embodiment, wherein adhesive sticker anchor log, such as adhesive phase, produces enough normal force with transmitting vibrations to skull, keeps reliability and comfortableness simultaneously, be included in one day or longer time frame use on.Fig. 7 shows the adhesive anchor log 700 that can be used in such as adult.Fig. 7 A is the three-dimensional view with the adhesive sticker anchor log 700 of upper adhesive phase 710, boss feature structure 720, supporting pad 730 and lower adhesive phase 740 assembled completely.This adhesive anchor log can be shaped as by after providing concave edge edge 732 and flange 734 to be placed on ear.Fig. 7 B is vertical view (upper figure) and end view (figure below), and exemplary dimensions (unit is inch) is shown.Fig. 7 C is the equivalent diagram of Fig. 7 A, and wherein all parts separately, also show the relative position of supporting pad upper surface 736 and lower surface 738.
Fig. 8 is the end view of the hearing aids 800 that the outside with outer part (such as, by sound wave conversion and the vibrator 810 zooming into vibration) is installed.It is D that hearing aids pad 820 has contact size 1external component surface 825.On the one hand, the dimension D on external component surface 1between about 1 centimetre and 2 centimetres.The external component surface 825 of pad 820 is connected to adhesive sticker anchor log, otherwise adhesive sticker anchor log is connected to user surface, as shown in figs. 9-10.The opposite side 824 of pad 820 is connected to hearing aids vibrator part 810 quiveringly.An example of bone vibration hearing aids 800 provides in fig. 11, and it comprises the vibrator part 810 being connected to the hearing aids pad 820 with outer surface 825.
With reference to Fig. 9, other people the adhesive anchor log that uses being suitable for children or having the mastoidea of relative small size or a region is the form with round-shaped adhesive phase 710.Fig. 9 A illustrates vertical view (left figure) and the end view (right figure) of the adhesive sticker anchor log 710 corresponding to adhesive phase (in the present embodiment, two-sided tape).Fig. 9 B shows the adhesive sticker anchor log 710 used together with hearing aids pad 820 hearing aids to be connected to the user surface 855 corresponding to the skin histology 860 covering head area (being represented by the bone 870 with surface curvature 865).In the present embodiment, hearing aids pad 820 (there is the flat contact surfaces for external component surface 825) and cover there is the bone 870 of curved surface 865 adhesive sticker anchor log 710 between interaction produce power and distribute 831,841.The distribution of this power is reflected as the direction along the power arrow 831 and 841 passing tissue 860 on interior zone 830 and perimeter 840 respectively.
Figure 10 shows the system (also see Fig. 7) typically having and use than the adult in the larger mastoid region for children.Supporting pad 730 is combined in adhesive sticker anchor log.Supporting pad 730 is smooth (Figure 10 A) in the situation of shelving.In mastoid 870 and surface of bone 865, lower adhesive phase 740 is with user's surface 855 bringing into conformal contact and bond to user surface 855.Adhesive phase is consistent with the curvature on user surface 865.Therefore, in use (see Figure 10 B), hearing aids pad 820 is such as connected to supporting pad 730 via upper adhesive phase 710.Optionally, upper adhesive phase 710 corresponds to the adhesive anchor log 710 shown in Fig. 9 A.Optionally, upper adhesive phase is not corresponding with the adhesive anchor log for children, such as, have and special different size, shape and/or the composition applied for being grown up, and is applicable to especially and/or coupling external component surface 825.With reference to Figure 10 B, supporting pad 730 and lower adhesive phase 740 are selected to have suitable bending rigidity and adhesive strength respectively, make the outward flange of supporting pad 730 under the flexing masterpiece produced by lower adhesive phase is exerted oneself, make supporting pad 730 deflect down from flat condition and be bent into case of bending (comparison diagram 10A and Figure 10 B 730).When the state of shelving at the edge deflected is positioned as towards hearing aids, the outer rim of deflection produces normal force 841 along the direction towards hearing aid device in surface texture 860.Because lower adhesive phase 740 has sufficiently high adhesive adhesive strength to prevent and any one delamination in surface 855 and 825, the normal force 841 therefore produced by the end of supporting pad 730 is delivered to tissue 860 by perimeter 840.Therefore dynamic balance needs in the middle section 830 of tissue, to produce equal and opposite in direction and the contrary normal force 831 in direction.The power of this middle section 830 is restricted to the area such as corresponding to hearing aids pad, therefore between external vibration hearing aids and user's bone 870, provides good contact force.
Similar principle occurs in figures 9 b and 9, except hearing aids spacer has high bending stiffness also in use indeformable and the outward flange of pull-up tissue 860.
Alternatively, this adhesive phase can be connected to magnet, otherwise magnet is connected to external component surface 825.By minimizing the suitable worry of aiming between adhesive with external component surface, such magnet is useful at auxiliary hearing aids 800 in the location on user surface and installation.
Finite element analysis (FEA): FEA be used for determining in use hearing aids process deflection plastics ear pad with the power needed for the Curvature Matching of the bone below this plastics ear pad.This analysis is relevant to the suitable adhesive selecting to use together with specific plastics ear pad the Nomenclature Composition and Structure of Complexes.Particularly, the deflection in use of plastics ear pad or flexing contribute in use producing suitable power distribution.Typical range of deflection corresponding to the curvature of head area is about 0.165 inch.The material behavior of the adhesive sticker anchor log of Fig. 7 is modeled into unfilled injection moulding Merlon.Load is applied in until realize the deflection of 0.165 inch.
The result that silicon chip FEA tests shows that the power of 1.65 pounds of the outer end being applied to adhesive sticker anchor provides required deflection.Stress calculation under this deflection is about 3000psi.In some aspects, the material behavior of adhesive sticker anchor log is selected as avoiding creep of plastics, and creep of plastics will functionally cause contact force to reduce in time.Alternately or in addition, this anchor log is disposable, made before large creep of plastics occurs, this anchor log is thrown away.
Example 4: spring
Fig. 5-6 illustrates an embodiment, and wherein adhesive anchor log 5 comprises attaching components and spring-like member.Fig. 5 illustrates that first end 512 place being included in cantilever is connected to the adhesive anchor log 5 of the adhesive 500 of cantilever 510.Second end 514 of cantilever is operably connected to external component 20 to produce normal force 15, is fixed by external component 20 against user surface 17.In this example, the second end 514 locating towards outer surface 12 against external component 20, to apply normal direction bed knife 15.Or the second end 514 can be located against another surface (such as upper surface, lower surface, side or their combination), to produce normal force.The advantage being connected to surface 12 is that unbalanced power or moment are easily minimized or avoids, and power crosses contact surface area distribution better, and avoids undesirable pressure spot.On the one hand, external component have be shaped or bend for have corresponding shaping or curved surface user surface 17 bringing into conformal contact towards interior surface, reduce further risk that is uncomfortable and undesirable pressure spot thus.
Fig. 6 is that wherein adhesive anchor log comprises the embodiment of adhesive 600 and spring 610.Contrast with the embodiment of Fig. 5, in Fig. 5, the cantilever 510 fixed by adhesive 500 produces normal force, the embodiment of Fig. 6 relies on the tension force of adhesive 600 generation, to transfer to produce normal force, this normal force is passed to the part of the transducer 11 against the fixing external component in user surface 17 via spring 610.Adhesive 600 can be have the first end 620 of the primary importance 622 being fixed to user surface 17 and be fixed to the adhesive tape of the second end 624 of the second place 626 on user surface 17.Primary importance 622 and the second place 626 are separated by spacing distance 628.Adhesive tape 600 has the middle body 621 between end 620 and 624, and this middle body 621 is more specifically limited by the part contacted with external component 20, to provide fixing normal force 15.In one embodiment, the length percent of adhesive tape middle body is selected from the scope between about 30% and 60%.In one embodiment, middle body 621 contacts with external component 20 at outside housing unit 640 place.This external shell assembly has the second surface 644 of the first surface 642 being connected to spring element 610 and the middle body 621 being connected to adhesive tape 600.Each spring element 610 of any amount can be used for providing and is applied to power on surface 644 to being applied to the good and uniform power transmission of power applied against user surface 17.In one embodiment, the inner surface of the external component contacted with user surface 17 is shaped accordingly the shape into user surface, to avoid undesired pressure spot and to improve comfortableness.On the one hand, the shape of the inner surface of external component is special for each user, such as, by obtaining the mould on user surface and forming the inner surface of external component with this mould.
Adhesive 600 can be the known in the art any material being reversibly attached to user surface 17 (particularly covering the skin in the region expecting fixing hearing devices).On the one hand, this adhesive is adhesive tape, such as medical adhesive tape or surgical tape (such as, 3M Micropore tMor surgical tape).Alternately, adhesive 600 can be reversibly arrange in pairs or groups with mating member (such as to be taken by buckle, nylon band etc.) fastener type system, make this device reversibly can be connected to user.On the one hand, this part being connected to the anchor log of the external component of hearing devices can more for good and all connect, and is connected to the end structure of the anchor log of user for can reversibly remove.Alternatively, adhesive anchor log part reversibly can be connected to external component, and external component can be removed from this adhesive anchor log.
On the one hand, adhesive anchor log comprises the adhesive tape of the geometry with restriction.In one embodiment, this shape is roughly and has the substantially rectangular of two ends limited.Alternately, other shapes can be used, such as to provide the contact with the increase on user surface.An example is the sticking outer peripheral adhesive tape in order to contact user surface of tool.Such shape can be the circle, avette, the oval or rectangle that cover external component, 640 of such as Fig. 6 and 11.In one embodiment, adhesive anchor log is further defined to the bonding contact area had with user's surface contact, such as, select from being more than or equal to 1 square centimeter and being less than or equal to the contact surface area of the scope of 10 square centimeters.
Run through all lists of references of the application, such as comprise mandate or the patent document of patent granted or equivalent; Patent application is open; With Non Patent Literature Documents or other materials of originating, be incorporated herein by reference with its full content at this, as being incorporated to separately by reference, prerequisite is that each list of references is not inconsistent (such as with the disclosure in the application at least partly, except the part that the part of list of references is inconsistent, the inconsistent list of references of this part is incorporated to by reference).
The all patents mentioned in this manual and publication embody the level of skill of those skilled in the art.The list of references quoted herein is incorporated to herein with its full content to embody the state of prior art by reference, in some situation from its applying date, if and be intended that this information need can use in this article, to get rid of the specific embodiment that (such as, abandoning) belongs to prior art.Such as; when claimed a kind of compound; should be understood that compound well known in the prior art, comprise some compound disclosed in list of references disclosed herein (especially in quoted patent documentation), be not intended to be included in this claim.
The understandable the present invention of being of those skilled in the art is applicable to realizing the target mentioned and also obtains the result and advantage mentioned and the intrinsic result of those the present invention and a little very much.The method of the representative as current preferred embodiment described herein, parts, material and size only provide as an example, are not intended as the restriction to scope of the present invention.Those skilled in the art are included in the change wherein in spirit of the present invention and other purposes by expecting, and described change wherein and other purposes are included within the scope of claim.
Although description herein comprises some specific information and example, these scopes that should not be construed as limiting the invention, and be only to provide this explanation to some embodiments of invention.Therefore, other embodiments are also in claim within protection scope of the present invention and below.
No matter when provide a scope in the description, such as, the scope of temperature range, time range, distance range, surface area scope, percentage range or power, all intermediate ranges and subrange and all each values be included in given range are all intended to be included in the disclosure.
As used herein, " comprising " and " comprising ", " containing " or " being characterised in that " are synonyms, and are inclusives or open, and do not get rid of element that is other, that do not state or method step.As used herein, " by ... composition " do not comprise any unspecified parts, step or composition in the claims.As used herein, " substantially by ... composition " does not get rid of material or the step of the fundamental sum novel feature not affecting claim in essence.Any citation that term herein " comprises ", particularly in the description of the description of the component of composition or the element of device, should be understood to contain those substantially by with the composition be made up of quoted from parts or element and method.The present invention described illustratively herein can be properly implemented when lacking any one or more elements not disclosed especially, one or more restriction herein.
List of references:
Holgers etc., the soft tissue reaction around skin implant: for the soft tissue condition clinical research around the skin penetration titanium implant of bone anchor formula hearing aids.USA Magazine Otology 1988, January; 9 (1): 56-9.
McDermott, A.L. etc., Birmingham children's's bone anchor formula hearing aids project: the experience of 15 years.OtolNeurotol,2009.30(2):p.178-83.
Holgers et al.Soft tissue reactions around reactions around percutaneousimplants:a clinical study of soft tissue conditions around skin-penetratingtitanium implants for bone-anchored hearing aids.American Journal of Otology1988
Jan;9(1):56-9.
McDermott,A.L.,et al.,The birmingham pediatric bone-anchored hearingaid program:a 15-year experience.Otol Neurotol,2009.30(2):p.178-83.
Lloyd,S.,et al.,Updated surgical experience with bone-anchored hearingaids in children.J Laryngol Otol,2007.121(9):p.826-31.
Monksfield,P.,et al.,Experience with the longer(8.5mm)abutment forBone-Anchored Hearing Aid.Otol Neurotol,2009.30(3):p.274-6.
van de Berg,R.,et al.,Bone-anchored hearing aid:a comparison of surgicaltechniques.Otol Neurotol,2010.31(1):p.129-35.
Stalfors,J.and A.Tjellstrom,Skin reactions after BAHA surgery:acomparison between the U-graft technique and the BAHA dermatome.OtolNeurotol,2008.29(8):p.1 109-14.
de Wolf,M.J.,et al.,Nijmegen results with application of a bone-anchoredhearing aid in children:simplified surgical technique.Ann Otol Rhinol Laryngol,2008.117(11):p.805-14.
Wazen,J.J.,et al.,Successes and complications of the Baha system.OtolNeurotol,2008.29(8):p.1115-9.
Priwin,C.and G.Granstrom,The bone-anchored hearing aid in children:asurgical and questionnaire follow-up study.Otolaryngol Head Neck Surg,2005.132(4):p.559-65.
Badran,K.,et al.,Long-term complications of bone-anchored hearing aids:a 14-year experience.J Laryngol Otol,2009.123(2):p.170-6.
de Wolf,M.J.,et al.,Bone-anchored hearing aid surgery in older adults:implant loss and skin reactions.Ann Otol Rhinol Laryngol,2009.118(7):p.525-31.
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Claims (20)

1., for the hearing aids installed from the outside system to user's skull transmitting vibrations, this system comprises:
External component surface; With
Adhesive sticker anchor log, for described external component surface being reversibly fixed to the user surface covering head area,
Wherein, in use, described external component surface produces normal force distribution with the described adhesive sticker anchor log being connected to described head area, the direction that the distribution of described normal force has power is away from the perimeter of described head area and the direction of the power middle section towards described head area, and described middle section provides enough contact force reliably vibration is delivered to described head area from described outside hearing aids between described external component surface and described head area.
2. the system as claimed in claim 1, wherein, described adhesive sticker anchor log is included in the adhesive phase between described user surface and described external component surface; And described adhesive phase is shaped as with described head area bringing into conformal contact and covers a part for described head area.
3. the system as claimed in claim 1, wherein, described external component surface for having the contact pad of the flat surfaces for being connected to described adhesive sticker anchor log, and is connected to the surface of relative positioning of vibrator of described hearing aid device quiveringly.
4. system as claimed in claim 3, wherein, it is circular surface configuration substantially that described flat surfaces has.
5. system as claimed in claim 4, wherein, described surface configuration has to be selected from and is more than or equal to 1 centimetre and the average diameter being less than or equal to the scope of 5 centimetres.
6. system as claimed in claim 3, wherein, described adhesive sticker anchor log comprises and has the surface configuration corresponding with the surface configuration of described contact pad flat surfaces and surface area and the adhesive phase of surface area.
7. the system as claimed in claim 1, wherein, described adhesive sticker anchor log comprises:
Supporting pad, has upper surface and lower surface;
Upper adhesive phase, for being connected to described external component surface by described supporting pad;
Lower adhesive phase, for being connected to described head area by described supporting pad.
8. system as claimed in claim 7, wherein, described supporting pad is formed for after being placed on ear, and the shape of described supporting pad has the concave edge edge for locate near ear and the flange relative with described concave edge edge for locating farthest apart from ear.
9. system as claimed in claim 8, wherein, described upper adhesive phase has upper adhesive layer surface shape, and the boss feature structure comprising and have the boss feature shapes corresponding with described upper adhesive layer surface shape is paid somebody's debt and expected repayment later in described maintenance, for receiving described upper adhesive phase.
10. system as claimed in claim 7, wherein, described supporting pad and described lower adhesive phase is each has and the surface configuration corresponded to each other.
11. systems as claimed in claim 7, wherein, described supporting pad has surface area and described external component surface has surface area, the surface area on described supporting pad and described external component surface than be selected from be more than or equal to 1 and be less than or equal to 5 scope.
12. systems as claimed in claim 7, wherein, described adhesive sticker anchor log has and is selected from following one or more physical property:
Thickness, is selected from and is more than or equal to 0.1 millimeter and the scope being less than or equal to 5 millimeters; With
Clean bending rigidity, about 0.8 pound to 2.5 pounds be applied to the effect of the load of outer end under, the outer end tilt value of the scope being selected from 0.08 inch to 0.25 inch is provided.
13. systems as claimed in claim 12, wherein, the load of described applying is produced by the lower adhesive phase being connected to curved surface, and this curved surface correspondingly makes described supporting pad bend.
14. systems as claimed in claim 13, wherein, the load of described applying is selected from and is more than or equal to 1 pound and the scope being less than or equal to 2 pounds.
15. systems as claimed in claim 2, wherein, described adhesive phase is two-sided removable adhesive of medical.
16. 1 kinds, for hearing aids being connected to the adhesive sticker hearing aids pad on user surface, comprising:
Conformal supporting pad, has upper surface and lower surface;
Upper adhesive phase, is connected to the upper surface of described supporting pad, for described supporting pad being connected to the external component surface of hearing aids;
Lower adhesive phase, is connected to the lower surface of described supporting pad, for described supporting pad being connected to described user surface; With
Boss feature structure, receive on the upper surface at described supporting pad and fixed described on adhesive phase;
Wherein, in use, the deflection divided relative to inside is divided by outside, described supporting pad is consistent with the curvature on described user surface, with along described supporting pad outward flange produce towards upper power and produce in interior zone towards under power, to provide good contact between described conformal supporting pad and described user surface.
17. adhesive sticker hearing aids pads as claimed in claim 16, wherein, described upper adhesive phase is connected to the external component surface of hearing aids.
18. adhesive sticker hearing aids pads as described in claim 16 or 17, have the surface area of the scope being selected from 1 square centimeter to 15 square centimeters, and described surface area can obtain for contacting with the physical skin covering head area.
19. 1 kinds of methods bone conduction hearing device being fixed to the skin covering user head area, said method comprising the steps of:
Adhesive anchor log is positioned on the skin of the head area covering described user;
Bone conduction hearing device is connected to described adhesive anchor log;
Outside power is produced in the skin of outer beneath portions being positioned at described adhesive anchor log; With
By power outside described in the inside dynamic balance in the skin being positioned at beneath portions in described adhesive anchor log;
Wherein, described bone conduction hearing device is reliably fixed to described user by described inside power.
20. methods as claimed in claim 19, further comprising the steps of:
Described adhesive anchor log is out of shape with consistent with the shape of the mastoid process below described adhesive anchor log, produces outside power thus.
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